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Newcastle Disease Virus

Overview

Newcastle disease virus (NDV) is a virus that is of interest because it replicates (makes copies of itself) more quickly in human cancer cells than in most normal human cells and because it can kill these host cells (see Question 1).

NDV can be used to directly kill cancer cells, or it can be given as a cancer vaccine. Cancer vaccines cause the body's natural immune system to seek out and destroy cancer cells (see Question 4).

The results of clinical trials (research studies with people) of NDV as a cancer treatment have not proved that it works (see Question 6).

The US Food and Drug Administration has not approved NDV as a treatment for cancer (see Question 8).

Questions and Answers About Newcastle Disease Virus

What is Newcastle disease virus?

Newcastle disease virus (NDV) is a virus that causes a deadly infection in many kinds of birds. In humans, NDV causes mild flu-like symptoms or conjunctivitis (an infection of the eye that is also called pink eye) and/or laryngitis (an irritation and swelling of the voice box and the area around it).

Like other viruses, NDV infects cells (called host cells) and then uses those cells to replicate (make copies of) itself. Researchers are interested in NDV because it replicates itself more quickly in human cancer cells than in most normal human cells and it can kill the host cells. For these reasons, the virus is being studied as a treatment for cancer.

What is the history of the discovery and use of Newcastle disease virus as a complementary or alternative treatment for cancer?

The first report that NDV may be useful as a cancer treatment was published in 1964. For 20 years before this report, NDV was used in a vaccine to prevent Newcastle disease in birds. During that time, it was learned that NDV caused only minor illness in humans. The mild side effects caused by NDV in humans and its ability to replicate up to 10,000 times faster in human cancer cells than in most normal human cells, led complementary and alternative medicine researchers to look more closely at NDV as a possible cancer treatment. NDV is now being studied by conventional medicine researchers also.

What is the theory behind the claim that Newcastle disease virus is useful in treating cancer?

There are many strains of NDV, and they may be either lytic or nonlytic for human cells. Lytic strains kill the infected cell by damaging its outer membrane (layer of tissue). Nonlytic strains kill by blocking the basic processes a cell needs to live. Lytic strains of NDV have been studied in humans because they can kill cancer cells directly, but both lytic and nonlytic strains have been used to make vaccines to help the immune system fight cancer.

How is Newcastle disease virus administered?

The way NDV is given depends on how the virus is used to target cancer cells. It may be used to directly infect the patient with NDV or to make cancer vaccines. Cancer vaccines made with NDV may improve the body's natural immune response to cancer, causing it to attack and kill more cancer cells than it would if the NDV were not present. Researchers are studying 3 ways of using NDV as a possible cancer treatment:

Infection of the cancer patient with NDV

NDV can be injected directly into the tumor, a muscle, or a vein (intravenous injection), or into the colon. The virus can also be inhaled. As explained in Question 1, NDV infects cells and then replicates itself, creating more copies of the virus that can then infect cells throughout the body. This process targets and kills cancer cells by damaging the cells' outer membranes.

Oncolysate vaccine.

Oncolysate vaccines are made using pieces of cancer cell membranes infected with NDV. Oncolysate-based vaccines are injected under or into the skin.

Whole-cell vaccine

Whole-cell vaccines are made using whole tumor cells infected with NDV. The tumor cells used in the vaccine are changed in the laboratory so that they cannot multiply or infect the patient. Whole-cell vaccines with NDV are given only by injection under the skin.

Have any preclinical (laboratory or animal) studies been conducted using Newcastle disease virus?

A number of preclinical studies have been done with NDV. Research in a laboratory or using animals is done to find out if a drug, procedure, or treatment is likely to be useful in humans. These preclinical studies are done before any testing in humans is begun. The following has been learned from preclinical studies:

NDV replicates more quickly in human cancer cells than in any other type of cell.

Some types of NDV are able to directly kill certain types of cancer cells.

NDV and NDV-infected cancer cells can cause the immune system to respond in different ways.

A few of these studies used human cells, but most used animal cells. Based on these and other laboratory findings, clinical trials (research studies with people) using NDV were begun.

Have any clinical trials (research studies with people) of NDV been conducted?

Clinical trials of NDV have been done but have not proven that NDV is effective as a cancer treatment. Some of the trials reported positive results and some did not. Most of the studies enrolled only small numbers of patients who also received standard treatments. None of the trials published in English were randomized and few were controlled. Randomized clinical trials give the highest level of evidence. In randomized trials, volunteers are assigned randomly (by chance) to one of 2 or more groups that compare different factors related to the treatment. In a controlled clinical trial, one group (called the control group) does not receive the new treatment being studied. The control group is then compared to the groups that receive the new treatment, to see if the new treatment works. Randomized controlled trials, enrolling larger numbers of people, are needed to confirm the results of studies done so far on the use of NDV to treat cancer.

Clinical trials studying the use of NDV as a cancer treatment have been done in the United States, Canada, China, Germany, and Hungary. Below are brief descriptions of these studies.

Studies Using Oncolysate Vaccines

Four clinical trials in the United States studied the use of NDV oncolysates in patients with metastatic melanoma. Three of these studies, a phase I clinical trial and 2 phase II clinical trials, were by the same group of researchers. Some positive results were found in these studies. The fourth trial was led by different researchers and showed no benefit. The same type of NDV was used to make the vaccines in all 4 studies, but the 2 groups of researchers used different methods to make them. Results from these studies need to be confirmed by randomized controlled trials that enroll larger numbers of people.

Two other phase II trials of NDV oncolysates were done in Germany. One of the studies showed that people in the trial had longer disease-free survival when compared with published information on similar patients who were treated with surgery alone. Because these studies were not controlled and the patients received other treatments, it is not clear if it was the treatment with NDV oncolysates that caused the responses reported.

Studies Using Whole-cell Vaccines

Most of the published clinical studies of whole-cell vaccines with NDV have been done in Germany. The largest reported trial was in China. Most of these studies involved patients with colorectal cancer, breast cancer, ovarian cancer, renal cell (kidney) cancer, or malignant glioma. The same type of NDV was used to make the vaccines in all of the studies.

Some of these studies found improved disease-free survival or improved overall survival in patients treated with whole-cell vaccines. The lack of control groups and other weaknesses in study design and reporting made it unclear if benefits were caused by the whole-cell vaccine or by something else. Overall, the results showed that these vaccines may help the immune system kill more cancer cells during the vaccination program but may not provide long-term cancer immunity.

Studies Involving Infection with NDV (Including MTH-68)

Most research on the treatment of cancer by infecting patients with NDV has been done in Hungary, using the NDV strain MTH-68. The published findings include the following types of studies:

An anecdotal report (incomplete descriptions of the medical and treatment history of one or more patients).

A case report (a detailed report of the diagnosis, treatment, and follow-up of an individual patient).

A small case series (a group of case reports involving patients who were given similar treatment).

A phase II clinical trial.

According to the researchers, the MTH-68 treatment was helpful for most of the patients in these studies. The number of patients in the studies was small, however, and the patients in the clinical trial were not randomly assigned. The patients also received other treatments. For these reasons, it is not known if the patients were helped by the MTH-68 or by something else.

In the United States, a phase I clinical trial tested PV701, another type of NDV. In this trial, 79 patients with advanced cancers that were not helped by conventional therapy were given PV701 by injection into a vein. Some patients had partial responses to the treatment, while others did not have any change in their condition. More studies are planned.

One major concern is that repeated injections of NDV may cause a person's immune system to form antibodies against the virus. These antibodies would prevent NDV from infecting and killing cancer cells. More research is needed to study this.

While most studies of NDV in cancer treatment have been small and without control groups, there have been enough promising results to call for continued research.

Have any side effects or risks been reported from NDV?

The side effects caused by NDV exposure have been mild to moderate. As noted in Question 1, NDV causes mild flu-like symptoms, conjunctivitis, and laryngitis in humans. Other side effects vary with how the virus is given.

The most commonly reported side effect after treatment with the virus alone is fever, which usually goes away within 24 hours. In one study, inflammation and swelling were seen near some tumors. These complications may have contributed to the death of one patient.

The most common side effects of treatment with NDV-infected whole-cell vaccines are minor:

Mild headache.

Mild fever on the day of the vaccination.

Itching, swelling, and redness of the skin at the injection site.

The only negative effect of treatment with the NDV oncolysate vaccine is inflammation at the injection site.

Studies that combined treatment with NDV oncolysates or whole-cell vaccines with substances called cytokines reported flu-like symptoms, fever, and swelling. The side effects seen in these studies have been linked to the cytokine portion of the treatment.

Is Newcastle disease virus approved by the US Food and Drug Administration (FDA) for use as a cancer treatment in the United States?

The US Food and Drug Administration (FDA) has not approved Newcastle disease virus as a treatment for cancer.

Clinical Trials

General information about clinical trials is available from the NCI Web site.

Changes to This Summary (02 / 20 / 2013)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

About This PDQ Summary

About PDQ

Physician Data Query (PDQ) is the National Cancer Institute's (NCI's) comprehensive cancer information database. The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries come in two versions. The health professional versions have detailed information written in technical language. The patient versions are written in easy-to-understand, nontechnical language. Both versions have cancer information that is accurate and up to date and most versions are also available in Spanish.

PDQ is a service of the NCI. The NCI is part of the National Institutes of Health (NIH). NIH is the federal government's center of biomedical research. The PDQ summaries are based on an independent review of the medical literature. They are not policy statements of the NCI or the NIH.

Purpose of This Summary

This PDQ cancer information summary has current information about the use of Newcastle disease virus in the treatment of people with cancer. It is meant to inform and help patients, families, and caregivers. It does not give formal guidelines or recommendations for making decisions about health care.

Reviewers and Updates

Editorial Boards write the PDQ cancer information summaries and keep them up to date. These Boards are made up of experts in cancer treatment and other specialties related to cancer. The summaries are reviewed regularly and changes are made when there is new information. The date on each summary ("Date Last Modified") is the date of the most recent change.

The information in this patient summary was taken from the health professional version, which is reviewed regularly and updated as needed, by the PDQ Cancer Complementary and Alternative Medicine Editorial Board.

Clinical Trial Information

A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about the effects of a new treatment and how well it works. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become "standard." Patients may want to think about taking part in a clinical trial. Some clinical trials are open only to patients who have not started treatment.

Clinical trials are listed in PDQ and can be found online at NCI's Web site. Many cancer doctors who take part in clinical trials are also listed in PDQ. For more information, call the Cancer Information Service 1-800-4-CANCER (1-800-422-6237).

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The information in these summaries should not be used to make decisions about insurance reimbursement. More information on insurance coverage is available on Cancer.gov on the Coping with Cancer: Financial, Insurance, and Legal Information page.

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General CAM Information

Complementary and alternative medicine (CAM)—also referred to as integrative medicine—includes a broad range of healing philosophies, approaches, and therapies. A therapy is generally called complementary when it is used in addition to conventional treatments; it is often called alternative when it is used instead of conventional treatment. (Conventional treatments are those that are widely accepted and practiced by the mainstream medical community.) Depending on how they are used, some therapies can be considered either complementary or alternative. Complementary and alternative therapies are used in an effort to prevent illness, reduce stress, prevent or reduce side effects and symptoms, or control or cure disease.

Unlike conventional treatments for cancer, complementary and alternative therapies are often not covered by insurance companies. Patients should check with their insurance provider to find out about coverage for complementary and alternative therapies.

Cancer patients considering complementary and alternative therapies should discuss this decision with their doctor, nurse, or pharmacist as they would any therapeutic approach, because some complementary and alternative therapies may interfere with their standard treatment or may be harmful when used with conventional treatment.

Evaluation of CAM Approaches

It is important that the same rigorous scientific evaluation used to assess conventional approaches be used to evaluate CAM therapies. The National Cancer Institute (NCI) and the National Center for Complementary and Alternative Medicine (NCCAM) are sponsoring a number of clinical trials (research studies) at medical centers to evaluate CAM therapies for cancer.

Conventional approaches to cancer treatment have generally been studied for safety and effectiveness through a rigorous scientific process that includes clinical trials with large numbers of patients. Less is known about the safety and effectiveness of complementary and alternative methods. Few CAM therapies have undergone rigorous evaluation. A small number of CAM therapies originally considered to be purely alternative approaches are finding a place in cancer treatment—not as cures, but as complementary therapies that may help patients feel better and recover faster. One example is acupuncture. According to a panel of experts at a National Institutes of Health (NIH) Consensus Conference in November 1997, acupuncture has been found to be effective in the management of chemotherapy-associated nausea and vomiting and in controlling pain associated with surgery. In contrast, some approaches, such as the use of laetrile, have been studied and found ineffective or potentially harmful.

The NCI Best Case Series Program, which was started in 1991, is one way CAM approaches that are being used in practice are being investigated. The program is overseen by the NCI's Office of Cancer Complementary and Alternative Medicine (OCCAM). Health care professionals who offer alternative cancer therapies submit their patients' medical records and related materials to OCCAM. OCCAM conducts a critical review of the materials and develops follow-up research strategies for approaches deemed to warrant NCI-initiated research.

Questions to Ask Your Health Care Provider About CAM

When considering complementary and alternative therapies, patients should ask their health care provider the following questions:

What side effects can be expected?

What are the risks associated with this therapy?

Do the known benefits outweigh the risks?

What benefits can be expected from this therapy?

Will the therapy interfere with conventional treatment?

Is this therapy part of a clinical trial?

If so, who is sponsoring the trial?

Will the therapy be covered by health insurance?

To Learn More About CAM

National Center for Complementary and Alternative Medicine (NCCAM)

The National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) facilitates research and evaluation of complementary and alternative practices, and provides information about a variety of approaches to health professionals and the public.

NCCAM and the NIH National Library of Medicine (NLM) jointly developed CAM on PubMed, a free and easy-to-use search tool for finding CAM-related journal citations. As a subset of the NLM's PubMed bibliographic database, CAM on PubMed features more than 230,000 references and abstracts for CAM-related articles from scientific journals. This database also provides links to the Web sites of over 1,800 journals, allowing users to view full-text articles. (A subscription or other fee may be required to access full-text articles.) CAM on PubMed is available through the NCCAM Web site. It can also be accessed through NLM PubMed bibliographic database by selecting the "Limits" tab and choosing "Complementary Medicine" as a subset.

Office of Cancer Complementary and Alternative Medicine

The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) coordinates the activities of the NCI in the area of complementary and alternative medicine (CAM). OCCAM supports CAM cancer research and provides information about cancer-related CAM to health providers and the general public via the NCI Web site.

National Cancer Institute (NCI) Cancer Information Service

U.S. residents may call the NCI Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) Monday through Friday from 8:00 am to 8:00 pm. A trained Cancer Information Specialist is available to answer your questions.

Food and Drug Administration

The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective.

Who Cares: Sources of Information About Health Care Products and Services

Fraudulent Health Claims: Don't Be Fooled

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Web site: http://www.ftc.gov/

Last Revised: 2013-02-20

If you want to know more about cancer and how it is treated, or if you wish to know about clinical trials for your type of cancer, you can call the NCI's Cancer Information Service at 1-800-422-6237, toll free. A trained information specialist can talk with you and answer your questions.

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